Does acupuncture enhance the pain relief of chronic temporomandibular pain dysfunction syndrome (TMPDS) when combined with a the usual standard regime of resting splints and physiotherapy

ISRCTN	ISRCTN74414962
DOI	https://doi.org/10.1186/ISRCTN74414962
Protocol serial number	N0226132754
Sponsor	Department of Health
Funders	South Manchester University Hospitals NHS Trust (UK), NHS R&D Support Funding (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mrs Christine McNeil
Scientific

South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Phone	+44 (0)161 336 7433
Email	johnchrismc@ukgateway.net

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	If the addition of acupuncture to established treatment regimes for TMPDS: 1. Enhances pain relief over the short and long term (1 year) 2. Improves patient satisfaction with treatment 3. Is a cost effective addition to treatment in the long term It also aims to quantify the reduction in medication use: a potential cost saving to the NHS
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Temporomandibular disorder (TMD)
Intervention	1. Acupuncture combined with the usual standard regime of resting splints and physiotherapy 2. Usual standard regime of resting splints and physiotherapy alone
Intervention type	Other
Primary outcome measure(s)	Pain relief
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	06/06/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	60
Key inclusion criteria	30 patients with facial pain of temporomandibular or myofacial origin from the referrals to the consultants at the Maxillofacial Clinic (Mr JR Tuffin, Mr M Patel and Mr K Sanders) and 30 controls (recruited using randomly generated numbers).
Key exclusion criteria	1. Patients who have had surgery to the TMJ/head/neck or radiotherapy 2. Contradiction to the techniques: acupuncture/severe needle phobia, uncontrolled anti-coagulation/stainless steel allergy 3. Non-consenting patients 4. Unclear diagnosis 5. Dystonic facial muscles
Date of first enrolment	23/01/2003
Date of final enrolment	06/06/2004

South Manchester University Hospitals NHS Trust

Manchester
M23 9LT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan